Table 1

Concentration and Dosage of Anticaries Active Dentifrice/Rinse/Gel Ingredients Federal Register 21 CFR 355.10

Sodium fluoride


Dentifrices

Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Sodium fluoride 0.188 to 0.254% with an available fluoride ion concentration = 650 ppm.

Powders

Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a powdered dosage form: Sodium fluoride 0.188 to 0.254% with an available fluoride ion concentration of = 850 ppm for products containing the abrasive sodium bicarbonate and a poured-bulk density of 1.0 to 1.2 g/ml.

Treatment rinses

An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, monobasic, and phosphoric acid to a level of 0.1 molar phosphate ion and which yields an effective fluoride ion concentration of 0.02%.

An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, dibasic, and phosphoric acid to a pH of 3.5 and which yields an effective fluoride ion concentration of 0.01%.

Sodium fluoride 0.02% aqueous solution with a pH of approximately 7.

Sodium fluoride 0.05% aqueous solution with a pH of approximately 7.

Sodium fluoride concentrate containing adequate directions for mixing with water before using to result in a 0.02% or 0.05% aqueous solution with a pH of approximately 7.

Sodium monofluorophosphate

Dentifrices

Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Sodium monofluorophosphate 0.654 to 0.884% with an available fluoride ion concentration (consisting of PO3F= and F- combined) = 800 ppm.

Dentifrices containing 1,500 ppm theoretical total fluorine in a gel or paste dosage form. Sodium monofluorophosphate 1.153% with an available fluoride ion concentration = 1,275 ppm.

Stannous fluoride

Dentifrices

Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.

Stannous fluoride 0.351 to 0.474% with an available fluoride ion concentration = 700 ppm for products containing abrasives other than calcium pyrophosphate.

Stannous fluoride 0.351 to 0.474% with an available fluoride ion concentration = 290 ppm for products containing the abrasive calcium pyrophosphate.

Preventive treatment gel

Stannous fluoride 0.4% in an anhydrous glycerin gel, made from anhydrous glycerin and the addition of suitable thickening agents to adjust viscosity.

Treatment rinse

Stannous fluoride concentrate marketed in a stable form and containing adequate directions for mixing with water immediately before using to result in a 0.1% aqueous solution.


Zero BMC Oral Health 2006 6(Suppl 1):S9   doi:10.1186/1472-6831-6-S1-S9

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